CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices
This article was originally published in Start Up
Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.
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Investigational devices from CreatiVasc Medical, Blood Purification Technologies and the University of California, San Francisco were selected for CDRH’s “innovation pathway 2.0” program.
Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.
FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development.